Technical Field
The invention concerns the field of biomolecule formulation screening and stability testing. It concerns a method for the evaluation of the colloidal stability of liquid biopolymer solutions. The present invention describes a method for determining the stability of a liquid pharmaceutical composition comprising: a) providing a liquid pharmaceutical composition in a container, b) shaking said container on a shaker, whereby the shaker performs an oloid movement, c) determining the stability of said liquid pharmaceutical composition.
Background
The overall stability of biopharmaceutical formulations depends on various stability parameters like colloidal stability at the water/air interface, ice/water interface or its chemical stability, just to name a few.
In the early development phase time-to-clinic is crucial to be able to show proof of clinical concept of the development candidate. Any upfront loading of development activities should be avoided.
An important aspect for the development of a liquid formulation/liquid biopolymer solution, especially a protein formulation, is its sensitivity against mechanical stress and its chemical or colloidal stability. To determine these key criteria of a liquid formulation/liquid biopolymer solution, especially of a protein formulation, different mechanical stress studies can be conducted like a shear force study, a freeze/thaw study or a shaking study. Especially in early development phases it is of importance to perform such studies in a short time period. The overall development goal is to realize a short time lines until start of the first clinical trials. New and improved testing and screening methods are needed to help in realizing the tight time schedules of early stage development phases. There is, therefore, a need to accelerate the development of suitable biopharmaceutical formulations, especially for liquid formulations/liquid biopolymer solutions, such as protein formulations.